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Dear Sir
Please clarify
Can generic tablet be same in color and shape compare to innovator drug?
In the United States, trademark laws do not allow a generic drug to look
exactly like the brand-name drug. Is it accepable to FDA by having
different company logo and markings but with same in color and shape
compare to innovator drug?
Thanks
Chander
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Dear Chander
Thank you for your letter!
In my opinion, the generic drugs should not to be the same or exactly
looks like the innovator drug in color and shape. The reasons are
shown following:
First of all, it is doubted that the generic and innovator drug have a
totally the same effect. According to the concept given by FDA, a
generic drug is identical or bioequivalent, to a brand name drug in
dosage form, safety, strength, route of administration, quality,
performance characteristics and intended use. The bioequivalent only
means the active ingredients are the same. The inactive ingredients,
such as the fillers, dyes, or binders, are different between the
generic tablets and the innovation drug sometimes. This can
occasionally make a difference in the ADME, such as how quickly drug
is absorbed from the stomach or processed by the body. So the brand
name drug should be different from the generic drug in the color and
shape to discriminate them.
Second, generic drug companies may also receive the benefit of the
previous marketing efforts of the brand name drug company, including
media advertising, presentations by drug representatives and
distribution of free samples. Many of the drugs introduced by generic
companies have already been on the market for a decade or more, and
may already be well-known to patients and providers. So I think it is
immoral that make the generic drug looks exactly like the innovation
drug to confuse the patients meaningly. After all, not everyone
understands and can discriminate so many kinds of drugs like a
professional pharmaceutist or a clinical doctor.
Last, for the customs(patients), they always want to buy the most
effective and cheapest drug. As we know, generic drug has an big
advantage in price compared to the innovation drug. Further more, the
patients should at all times be aware of exactly what medications they
are receiving. It is necessary to make a difference in color and shape
of the generic drug and innovation drug to help patients decide which
drugs are need.
That's all. I appreciate your letter again.
Good luck!
Thacray
From Beijing China
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US law: You must be able to distinguish between the brand and the
generic in 6 seconds.
Milind
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The following message was posted to: PharmPK
Dear Milind,
Can you provide a reference for the same.
Regards,
Manpreet
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